Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
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|ClinicalTrials.gov Identifier: NCT05121545|
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : April 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Melanoma||Radiation: Pro-GRID||Not Applicable|
The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.
In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.
In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single arm phase I study design, evaluating the feasibility (primary endpoint), toxicity (secondary endpoint), and degree of response (exploratory endpoint) after proton GRID therapy in patients with bulky tumors.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)|
|Actual Study Start Date :||April 6, 2022|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2024|
Pro-GRID treatment Arm
Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction.
Study participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments.
Other Name: Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID
- Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants [ Time Frame: 1.5 years ]To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.
- Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4) [ Time Frame: 3 months post-treatment ]To determine the rate of mild acute toxicity, defined as any CTCAE grade 2 or lower toxicity, and severe acute toxicity, defined as any CTCAE grade 3 or higher toxicity.
- Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy [ Time Frame: 1, 6 and 12 months post-treatment ]To determine the change in response rate for bulky tumors treated and not treated with Proton GRID by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy [ Time Frame: 1, 6 and 12 months post-treatment ]Change in degree of treatment response would be measured by RECIST criteria (partial response, complete response, stable disease, or progression of disease).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05121545
|Contact: Jean Wright, MDfirstname.lastname@example.org|
|Contact: Dana Kaplin, MPHemail@example.com|
|Principal Investigator:||Jean Wright, MD||Radiation Oncology, SOM|